K-number	K213584
Device name	Reprocessed NRG Transseptal Needle
Applicant	Innovative Health, LLC
Product code	QLZ
Device class	Class II
Decision date	Apr 4, 2023
Decision	Substantially Equivalent
Regulation	870.5175

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Source

View the full FDA submission: accessdata.fda.gov

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Reprocessed NRG Transseptal Needle

Everything you need for a 510(k) submission. Nothing you don't.